FDA product code DFB: Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control
DFB is the FDA product code for alpha-1-antitrypsin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5130 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DFB. The average 510(k) review took 81 days (median 81).
Classification
| Field | Value |
|---|---|
| Device name | Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5130 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DFB clearance
Top DFB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1983-03-11 |
Most recent DFB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823829 | Bd Becton Dickinson Vacutainer Systems Preanalytic | FERRITIN IMMUNORADIOMETRIC ASSAY KIT | 1983-03-11 | 81 |
Recalls for DFB devices
openFDA lists no recalls for product code DFB.
Frequently asked questions
What is FDA product code DFB?
DFB is the FDA product code for alpha-1-antitrypsin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5130 and reviewed by the Immunology panel.
What device class is DFB?
Class II, regulation 21 CFR 866.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code DFB?
Across 1 cleared submissions the average was 81 days from receipt to decision (median 81).
Which companies have the most DFB clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DFB
- Run a recall and safety report across every DFB manufacturer
- Watch product code DFB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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